Previous Abdominal Surgery and Obesity Does Not Affect Unfavorably the Outcome of Total Laparoscopic Hysterectomy

NCT ID: NCT03738085

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Previous surgery and obesity has disputed as an unfavorable factor during Total Laparoscopic Hysterectomy. The aim of the investigator's study was to assess the effects of previous abdominal surgery and obesity on intra-operative and post-operative outcomes of TLH.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Abstract:

Objective: To assess the effects of previous abdominal surgery and obesity on the intra-operative and post-operative outcomes of total laparoscopic hysterectomy (TLH).

Method: In this retrospective cohort study, women who underwent TLH for benign conditions between January 2011 and December 2016 in tertiary academic center were included. Patients were grouped according to previous abdominal surgery. The study group consisted of patients who had at least one previous abdominal surgery and the control group consisted of patients with no previous abdominal surgery. In a further analysis, a subgroup of obese patients with BMI (body mass index) ≥30 kg/m2 was evaluated. For this analysis, the obese patients who underwent TLH were picked up and the results were compared to the results of obese patients who underwent total abdominal hysterectomy (TAH) during the same time period. The main outcome parameters were duration of hospital stay and major complication rate.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic Surgical Procedure Obesity Surgery--Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Previous abdominal surgery group

Previous abdominal surgery group underwent total laparoscopic hysterectomy

No interventions assigned to this group

No previous abdominal surgery group

No Previous abdominal surgery group underwent total laparoscopic hysterectomy

No interventions assigned to this group

Obese patients underwent TAH

BMI≥30 kg/m2

No interventions assigned to this group

Obese patients underwent TLH

BMI≥30 kg/m2

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all women who underwent TLH for benign conditions during study period
* all obese ≥30 kg/m2 women who underwent TAH for benign conditions during study period

Exclusion Criteria

* No
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Batuhan Turgay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Batuhan Turgay

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Bulent Berker, Professor

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AnkaraU-12-562-16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.